This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? Today, we’ll be talking to Mike Drues, president of Vascular Sciences, and he’s going to help us all understand what’s different about this fast track and how it might benefit you. Some of the highlights of the show include: ● What the new draft is about and how long this fast track has really been around. ● Some thoughts on the ramifications for ...
Nov 07, 2019•29 min•Ep 56•Transcript available on Metacast Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 510(k)? Many don’t understand it; the evidence is the large percentage of submissions that are rejected due to a lack of demonstrating substantial equivalence. Today we’re talking with Mike Drues, President of Vascular Sciences about demonstrating substantial equivalence, so if you’re not rock-solid on the concept, you won’t want to miss this episode. Some of the highlights of the show include: ● E...
Nov 07, 2019•34 min•Ep 57•Transcript available on Metacast What are the most common problems with the CAPA process? Today, frequent guest Mike Drues, president of Vascular Sciences and Jon are going to dive into that question and get you the answers you need and want. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● Why the CAPA process is such a big issue within the industry and why Jon wrote a column on it. ● What businesses are doing instead of focusing on CAPA and why this is one of the major problems with the process, as well as why a cross-functional...
Nov 07, 2019•40 min•Ep 59•Transcript available on Metacast Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to? Is it still just a checkbox activity? Or, are you ready to elevate yourself to be a true quality professional? A quality management system should help us run our business better and produce safer medical devices. It should be built well and run well - effective and efficient. On today’s episode, we have Larry Mager, a senior advisor for UL EHS Sustainability. He shares a tool he developed called...
Nov 07, 2019•25 min•Ep 58•Transcript available on Metacast When it comes to quality management compliance, would you consider yourself a box checker or a true quality professional? On today’s episode, we talk with Mike Drues, president of Vascular Sciences, about what it means to be a true quality professional and how to ensure your quality management system is effective and benefits patients. Do you want to offer medical devices that improve your patients’ quality of life? Don’t wait until an FDA audit to make changes or try and fix problems. Some of t...
Nov 07, 2019•35 min•Ep 60•Transcript available on Metacast When it comes to 13485:2016, are you scrambling to meet requirements? Are you trying to figure out the how, what, or when regarding its timeline? Or, maybe you just don’t know what you need to do. You are not alone because a lot of companies are behind. Don’t wait until it is too late. Now is the time to take action. Today’s guest is Kyle Rose, president of Rook Quality Systems, which helps companies achieve 13485 certification by using the Greenlight Guru’s Quality Management Software platform....
Nov 07, 2019•28 min•Ep 62•Transcript available on Metacast When developing a new medical device, do you try to figure out the fastest and simplest way to get your product to market? As a product developer, do you explore a regulatory path? Or, are you afraid that may kill your idea? Mike Drues, president of Vascular Sciences, is with us today to do some premarket approval (PMA) myth busting and describes why a PMA path may not be as scary as you think. Some of the highlights of the show include: ● PMAs are reserved for the highest risk devices (Class II...
Nov 07, 2019•40 min•Ep 63•Transcript available on Metacast Students offer hope for our future. They will be developing products that can save our lives, or at least improve our quality of life. We need to give them as much guidance and advice as possible. On today’s episode, we have Associate Professor Andrew DiMeo, who shares his mission and what he is trying to do with the biomedical program at the University of North Carolina and North Carolina State University. Some of the highlights of the show include: ● Andrew’s biomedical product development cou...
Nov 07, 2019•33 min•Ep 61•Transcript available on Metacast The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device Reporting (MDR). On today’s episode, we have Mike Drues, president of Vascular Sciences, to help us dive into the impact of this proposal and the safety of medical devices. The FDA proposal’s benefits probably outweigh the risks and should be implemented on a small scale. Some highlights of the show include ●Depending on the severity of the malfunction, you are given a specified amount of time to r...
Nov 07, 2019•31 min•Ep 65•Transcript available on Metacast Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the abbreviated path, it’s likely an accurate assumption that many don’t know how to use it. Today, Mike Drues, the president of Vascular Sciences, and Jon Speer are going to delve into the abbreviated 510(k) path and how it can benefit you. Some of the highlights of the show include: ● The three principal types of 510(k)s and how they differ from one another. ● The crux of the abbreviated 510(k) and h...
Nov 07, 2019•43 min•Ep 64•Transcript available on Metacast As companies transition from being a start-up or small company to a more established business and bring new medical devices to market, they tend to not put a lot of thought into their processes, systems, and approaches for regulatory strategies and quality systems. Regardless of the shape and size of your company, these factors are foundational to the growth and success of your business. Host Jon Speer and Mike Drues of Vascular Sciences discuss key tips on what to think about regarding regulato...
Nov 07, 2019•38 min•Ep 67•Transcript available on Metacast Have you ever designed a medical device that has electrical components? Was it frustrating to go through the electrical safety testing - the IEC 60601 standards? Claus Roemer Andersen, a compliance expert from Roemer Consulting, shares his experiences and advises us on how to design for compliance with IEC 60601. After all, a lack of electrical compatibility can be detrimental to medical devices and the patients who use them. IEC 60601 documentation is a lot to digest, which is a major challenge...
Nov 07, 2019•34 min•Ep 66•Transcript available on Metacast Sometimes, do things make you go, “Hhhmmmm…” Jon Speer recently watched a documentary about the medical device industry that made him do just that. Much of the information presented was factual, but it seemed liked the whole story was not being told. On today’s episode, Mike Drues, president of Vascular Sciences, joins Jon to explore different perspectives to give you a clear and complete picture of the industry. The documentary focused on a few medical devices that caused harm to people, but ne...
Nov 07, 2019•46 min•Ep 70•Transcript available on Metacast Are you familiar with FDA’s progressive programs for medical device companies? Do you know about Expanded Access, the Expedited Access Pathway (EAP) Program, or Breakthrough Devices Program (BDP)? Jon Speer discusses these programs with Mike Drues of Vascular Sciences. The FDA has created such programs to encourage companies to develop products that meet unmet clinical needs, and reduce the time and cost of bringing new or high-risk products from development to market without actually changing t...
Nov 07, 2019•36 min•Ep 72•Transcript available on Metacast These days, medical devices often include software or are standalone software. So, software as a medical device (SaMD) is a hot topic, and regulatory bodies have been updating regulations and launching new initiatives to seek applications being submitted for approval. However, a lot of confusion surrounds the how, what, and when to do things to meet FDA and other regulatory expectations. On today’s episode, we have Andrew Wu, a software consultant for Rook Quality Systems. He helps SaMD companie...
Nov 07, 2019•35 min•Ep 71•Transcript available on Metacast Human factors can be a tricky topic that creates confusion, especially when it comes to medical devices. On today’s episode, we have Mike Drues, president of Vascular Sciences, to help us dive deeper into nuances of human factors. The root cause for human factors related to medical devices is the watershed moment with infusion pumps that happened about 10 years ago. Did you know that infusion pumps are one of the most often recalled medical devices for safety reasons? This has led to rigorous te...
Nov 07, 2019•43 min•Ep 68•Transcript available on Metacast What is AI explainability? Why does it matter in health care? On today’s episode, we have Marla Phillips, director of Xavier Health, who shares why AI will transform how the medical device industry operates. Xavier Health brings the FDA and pharmaceutical and medical device industries together in a collaborative setting to break down barriers and improve patients’ health. Overcome the media-generated hype and fear of AI to discover its benefits when using it responsibly. We can do better with it...
Nov 07, 2019•32 min•Ep 69•Transcript available on Metacast Do you work with regulatory consultants to implement a quality system or 510(k), or perform other tasks? Are you asking your consultants the right questions? On today’s episode, Jon Speer talks to Allison Komiyama of AcKnowledge Regulatory Strategies about tips, pointers, and key questions to consider before hiring consultants to help you with quality and regulatory work. Many companies ask the wrong questions. Allison offers them the right questions to ask multiple consultants to find the best ...
Nov 07, 2019•44 min•Ep 77•Transcript available on Metacast Quality and regulatory professionals in the medical device industry have to deal with a lot. In this episode, Mike Drues of Vascular Sciences shares 15 of his highly effective habits and tips to help you lead your organization. You have an opportunity and obligation to explain the current regulatory structure in the industry - embrace it, don’t resist it! SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● Poker Game: Relationship between a company and the FDA is like a poker game; even if someone und...
Nov 07, 2019•43 min•Ep 74•Transcript available on Metacast Medical device standards seem to change and evolve all the time. Is it impossible to keep up with them? Do you know the latest and greatest when it comes to IEC 60601? FDA’s CDRH standards program? Consensus standards database? FDA’s ASCA pilot program? On today’s episode, we have Scott Colburn of the FDA and Leo Eisner of Eisner Safety Consultants to discuss what’s currently happening in the medical device industry when it comes to standards. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● New ve...
Nov 07, 2019•45 min•Ep 75•Transcript available on Metacast No matter what you are working on, there are risks involved. Product development is complicated.So, learn to embrace risk, and use it to your benefit to make your product safer. Think of what you can manage vs. what you can’t control. Our guest today is Tim Moulton of Motim Industries, who shares what you can do better to manage product development risk. Design and build a robust, viable product that's engineered for success in the market, works for users, and gets people excited! SOME OF THE HI...
Nov 07, 2019•36 min•Ep 73•Transcript available on Metacast What are some recent trends and observations in the medical device industry regarding regulatory affairs and strategies? On today’s episode, we have Allison Komiyama of Acknowledge Regulatory Strategies. She shares her perspective on them, especially as a former FDA reviewer, current consultant who helps companies with regulatory strategies and submissions, and patient of life-saving medical devices. Some of the highlights of the show include: ● The regulatory path to get devices approved has be...
Nov 07, 2019•32 min•Ep 78•Transcript available on Metacast FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medical device companies, manufacturers, and service providers to discuss biocompatibility, in vitro diagnostics, clinical trials, and other areas. On today’s episode, Mike Drues of Vascular Sciences and Jon talk about the advantages and disadvantages of this program that encourages reviewers and companies to spend more time together. The better the reviewers understand the development processes that me...
Nov 07, 2019•31 min•Ep 76•Transcript available on Metacast Are you in the midst of raising funds for a device that you are trying to bring to market? It can be challenging, and even more so due to the regulatory impact. Jon Speer of Greenlight Guru and Mike Drues of Vascular Sciences share tips to consider when raising funds for your medical device. Put yourself in your investor’s shoes, and be capital efficient - focus on the right things at the right time. Some of the highlights of the show include: ● Putting together a regulatory strategy executive s...
Nov 07, 2019•35 min•Ep 80•Transcript available on Metacast Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it really new? Or has its existing program just been repackaged? On today’s episode, I talk to Mike Drues of Vascular Sciences to determine the correct answer and what it means for you, your company, and medical device. Some of the highlights of the show include: ● FDA has 161 guidances now related to 510(k)s. Instead of more guidance, the solution should be to get people to think about and use 510(k) co...
Nov 07, 2019•45 min•Ep 82•Transcript available on Metacast How do you feel about pre-market approval (PMA) for Class III medical devices? Most businesses are not excited about products that require a PMA. But don’t look at it as the Kiss of Death. Embrace the PMA concept as a way to bring novel and unique devices to the market. Mike Drues of Vascular Sciences and I explore the topic of PMA. Lives depend on it! Some of the highlights of the show include: ● Efforts are being made to entice acceptance of PMAs by requiring less clinical data and testing to ...
Nov 07, 2019•44 min•Ep 81•Transcript available on Metacast What is true quality? How do you achieve it? In this episode, Jon Speer of Greenlight Guru and Mike Drues of Vascular Sciences discuss habits of highly effective, true quality medical professionals. True quality does not simply refer to being compliant with regulations - but going above and beyond. It’s your responsibility to improve the quality of life. Some of the highlights of the show include: ● Habit 1: Quality management system (QMS) should be simple and right sized; customize it to descri...
Nov 07, 2019•44 min•Ep 79•Transcript available on Metacast Are you confused by regulatory terminology? Clearance. Approval. Granted. Do these terms matter or make a difference when it comes to medical devices and working with the FDA? Yes, they do! Mike Drues of Vascular Sciences joins me to talk about the differences between clearance vs. approval vs. granted, which are the three most common ways medical devices are brought to market. Some of the highlights of the show include: ● Clearance: When a 510(k) is cleared from the FDA. Approval: When a PMA is...
Nov 07, 2019•32 min•Ep 84•Transcript available on Metacast There are a few additional steps to take when it comes to the Medical Device Single Audit Program (MDSAP) and ISO 13485-2016 regulatory process to get appropriate marketing clearances or approvals. If you go through a regulatory process and get a product cleared, you still need to make sure your product is properly registered with the appropriate regulatory agencies. These extra steps to actually sell your product can be complicated. On today’s episode, I talk to Jim Gianoutsos of RIMSYS Regulat...
Nov 07, 2019•38 min•Ep 83•Transcript available on Metacast Medical device quality and regulatory professionals face changes, challenges, requirements, standards, and so much more. It’s a challenge for them to keep up. In this episode, Mitch Robbins, founder and managing director of The Anthony Michael Group, offers tips for Quality Assurance and Regulatory Affairs (QA/RA) professionals on how to prepare for such a career. Some of the highlights of the show include: ● The Anthony Michael Group is executive search firm that focuses on the medical device i...
Nov 07, 2019•30 min•Ep 117•Transcript available on Metacast 
